Joint Pain and Medication Adherence in Postmenopausal Women Receiving Aromatase Inhibitors

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Vanderbilt University
Sponsor:
Collaborators:
American Cancer Society, Inc.
Information provided by (Responsible Party):
Liana Castel, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00954564
First received: August 6, 2009
Last updated: June 11, 2013
Last verified: June 2013
  Purpose

RATIONALE: Gathering information over time about joint pain and stiffness from postmenopausal women with early-stage breast cancer who are receiving aromatase inhibitors may help doctors plan treatment and help patients live more comfortably.

PURPOSE: This observational epidemiologic cohort is designed to study arthralgia, patient-reported outcomes, and medication adherence in postmenopausal women with early-stage breast cancer who are receiving aromatase inhibitors.


Condition Intervention Phase
Arthralgia
Breast Cancer
Other: aromatase inhibition therapy - OBSERVATIONAL ONLY
Other: medical chart review
Other: questionnaire administration
Procedure: assessment of therapy complications
Phase 1

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Arthralgia and Medication Adherence in Women With Early Stage Breast Cancer Taking Aromatase Inhibitors: The Breast Cancer Adjuvant Therapy (BCAT) Longitudinal Cohort Study.

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Arthralgia incidence, defined as proportion of the baseline population (those who have taken ≥ 9 doses of aromatase inhibitor [AI]) in which new or worsening joint pain or stiffness is observed at 1, 3, and 12 months after beginning AI therapy [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Time to onset of arthralgia (continuous variable in weeks) among baseline population [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Arthralgia point prevalence, defined as proportion of the baseline population with a score of ≥ 2 on any one dimension of the outcome measure at 1, 3, and 12 months after beginning AI therapy [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Symptom trajectories over the course of treatment [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Patient well-being: sleep quality, mood, and physical function [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 580
Study Start Date: June 2009
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: aromatase inhibition therapy - OBSERVATIONAL ONLY
    Observational only - as prescribed
    Other: medical chart review
    Observational only
    Other: questionnaire administration
    Observational only
    Procedure: assessment of therapy complications
    Observational only
Detailed Description:

OBJECTIVES:

Primary

  • Estimate the incidence, time to onset, prevalence, and clinical and demographic predictors of arthralgia in post-menopausal women with early-stage breast cancer receiving aromatase inhibitors (AI).
  • Chart the trajectory of arthralgia symptom severity over the course of AI treatment in these patients.

Secondary

  • Measure the impact of arthralgia on sleep quality, depression, and physical function in these patients.
  • Develop a roster of current physician-advised or prescribed treatments, including self-management techniques being used for AI-induced arthralgia, for intervention development.

OUTLINE: Patients complete questionnaires about joint pain and stiffness, sleep, depression, physical function, medications and treatment, exercise and social support, demographics, comorbidities, body mass index (BMI), and performance status at baseline and then periodically for approximately 1 year after beginning aromatase inhibitor (AI) therapy.

Patient medical records are reviewed for comorbidities, BMI, use of prior hormone replacement therapy, vitamin D levels and deficiency, performance status, histological stage, prior treatment, and medications at baseline and then periodically for approximately 1 year after beginning AI therapy.

  Eligibility

Ages Eligible for Study:   35 Years to 90 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Postmenopausal women with breast cancer initiating aromatase inhibitor therapy

Criteria

DISEASE CHARACTERISTICS:

  • Planning to begin aromatase inhibitor (AI) therapy or taken fewer than 10 doses of adjuvant AI therapy
  • Hormone-receptor status not specified

PATIENT CHARACTERISTICS:

  • Postmenopausal
  • ECOG performance status 0-1
  • Able to understand and respond to questions in English
  • No condition that would impair the ability to provide informed consent
  • No other non-breast cancer condition

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No more than 9 prior doses of AI
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00954564

Locations
United States, Tennessee
Vanderbilt-Ingram Cancer Center Recruiting
Nashville, Tennessee, United States, 37203
Contact: Liana Castel, PhD, MSPH    615-343-9798      
Vanderbilt-Ingram Cancer Center Recruiting
Nashville, Tennessee, United States, 37232-6838
Contact: Clinical Trials Office - Vanderbilt-Ingram Cancer Center    800-811-8480      
Sponsors and Collaborators
Vanderbilt University
American Cancer Society, Inc.
Investigators
Principal Investigator: Liana Castel, PhD, MSPH Vanderbilt-Ingram Cancer Center
  More Information

Additional Information:
No publications provided by Vanderbilt University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Liana Castel, Assistant Professor, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00954564     History of Changes
Other Study ID Numbers: CDR0000650647, UL1RR024975, VU-VICC-BRE-0939, 119475-MRSG-10-169-01-PCSM
Study First Received: August 6, 2009
Last Updated: June 11, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt University:
arthralgia
stage I breast cancer
stage II breast cancer
stage IIIA breast cancer

Additional relevant MeSH terms:
Arthralgia
Breast Neoplasms
Joint Diseases
Musculoskeletal Diseases
Pain
Signs and Symptoms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 15, 2014